483
Sunrise Pharmaceutical, Inc.FDA 483 - Sunrise Pharmaceutical, Inc. - March 31, 2026
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An FDA inspection of Sunrise Pharmaceutical, Inc. in Rahway, NJ, identified a critical issue regarding the storage of drug products. The firm failed to store products under appropriate temperature conditions, lacking scientific rationale and comprehensive seasonal mapping for warehouse temperature monitoring. This deficiency could compromise the identity, strength, quality, and purity of their drug products.
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